UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of muscle fatigue relieving or recovery effect of propolis-containing food.
Acronym	Evaluation of muscle fatigue relieving or recovery effect of propolis-containing food.
Scientific Title	Evaluation of muscle fatigue relieving or recovery effect of propolis-containing food.
Scientific Title:Acronym	Evaluation of muscle fatigue relieving or recovery effect of propolis-containing food.
Region	Japan

Condition
Condition	Healthy subject
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine the relieving and recovery effect of propolis for muscle fatigue when the subjects take propolis for 1 weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Muscle stiffness, voluntary muscle strength, and muscle activity are measured 1 week after intake.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Propolis Intake:787.5 mg Ingesion:7 days
Interventions/Control_2	Propolis Intake:100 mg Ingesion:7 days
Interventions/Control_3	placebo Ingesion:7 days
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	35 years-old >=
Gender	Male
Key inclusion criteria	1. Healthy Japanese men aged greater than or equal to 18 years, less than 35 years at the time of obtaining informed consent. 2. Subjects who can walk independently and can measure physical exercise performance. 3. Subjects who do not plan to change their lifestyle habits for a test period.
Key exclusion criteria	1. Subjects who have a history of asthma or current medical history. 2. Subjects who have allergies to bee products (honey etc.), conifers, trees of Pinaceae, poplar and salicylic acid. 3. Subjects who have serious illness or medical history such as diabetes, liver disease, kidney disease, heart disease. 4. Subjects who have medical history or history of food allergies or current medical history. 5. Others who judged that the investigator is inappropriate as the subject.
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Akagi
Organization	Shibaura Institute of Technology
Division name	Systems engineering and Science
Zip code	337-8570
Address	307 Fukasaku,Minuma-ku, Saitama-shi, Saitama
TEL	048-720-6021
Email	rakagi12@shibaura-it.ac.jp

Public contact
Name of contact person	1st name Ryota Middle name Last name Akagi
Organization	Shibaura Institute of Technology
Division name	Systems engineering and Science
Zip code	337-8570
Address	307 Fukasaku,Minuma-ku, Saitama-shi, Saitama
TEL	048-720-6021
Homepage URL
Email	rakagi12@shibaura-it.ac.jp

Sponsor
Institute	Shibaura Institute of Technology
Institute
Department

Funding Source
Organization	Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shibaura Institute of Technology Biotechnology Research Ethics Committee
Address	3-7-5 Toyosu, Koto-ku, Tokyo
Tel	03-5859-7340
Email	tgakuji@ow.shibaura-it.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 08 Month 21 Day
Date of IRB	2019 Year 08 Month 21 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2019 Year 12 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 18 Day
Last modified on	2021 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043359